Research Article


Shailendra Bindaiya1*, Ameeta Argal2
 1Research Scholar, Institute of Pharmaceutical Science and Research Center,
Bhagwant University, Sikar Road, Ajmer, Rajasthan, India
2Department of Pharmaceutical Chemistry, Rajeev Gandhi College of Pharmacy,
Kolar Road, Bhopal, Madhya Pradesh, India
Bull. Pharm. Res. 2012;3(2):44-50.

A simple, selective, rapid, precise and economical RP-HPLC stability-indicating method has been developed and validated for the quantitative estimation of orlistat (API) and their degradation products. Chromatographic separation was accomplished using C18 column with mobile phase consisting of acetonitrile:0.1% formic acid (85:15, v/v), flow rate was 1.0 ml/min and the detection wavelength was 215 nm. The method was validated for linearity, accuracy, precision, specificity and robustness. The API was subjected to stress condition of acid decomposition (0.1 N HCl refluxed for  8 h at 80°C), alkali decomposition (0.1 N NaOH refluxed for 8 h at 80°C), neutral hydrolysis (Distilled water refluxed for 12 h at 80°C), oxidative decomposition (3% H2O2 for 24 h at RT), thermal decomposition (Drug at 100°C for 24 h), photolytic decomposition (70,000-80,000 lux at 7 days). Percentage of degraded products were 13.37, 9.23, 1.44 and 5.04 for acid, alkali, neutral hydrolysis and oxidative decomposition respectively. No degradation was observed in thermal and photolytic conditions. Forced degradation study showed that orlistat is labile in acid, alkali, neutral and oxidative conditions. It is stable to light and dry heat. No interference of degradation products was found at the retention time of principal peak. The assay can be recommended for analysis of the API and degradation products in stability samples. It may be applied to a routine analysis in industries.

Key words: Orlistat, RP-HPLC, Stability indicating assay, Degradation, Method validation.

*Correspondence: Mr. Shailendra Bindaiya ([email protected])

(References: 21, Total Pages: 07)
(Received: April 27, 2013, Accepted: May 12, 2013)

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